LIFESCAN ISSUE URGENT MEDICAL DEVICE CORRECTION
This
affects: OneTouch® Ultra®, OneTouch®
FastTake®, InDuo®, EuroFlash®, SmartScan®, and PocketScan® Meters--
April 12, 2005
If
you use a OneTouch® Ultra®, OneTouch® FastTake®, InDuo®, EuroFlash®, SmartScan®, or PocketScan® Meter,
we want to make you aware of two possible issues regarding these products.
1.
CERTAIN
OneTouch Ultra Systems and all OneTouch
FastTake, EuroFlash, SmartScan, PocketScan and InDuo Systems are designed to show results in two different
units of measure. When setting the time and date on these meters, it is
possible for you to accidentally change the unit of measure. You may
misunderstand your blood glucose results if your meter is set to the wrong unit
of measure. Your meter's unit of measure should be set to "mmol/L," as shown on the meter display under the test
result.
In
countries where "mmol/L" is the standard
unit of measure, LifeScan has chosen to replace--free
of charge--all OneTouch FastTake,
EuroFlash, SmartScan, PocketScan and InDuo Systems, as
well as those OneTouch Ultra Systems that allow users
to change the unit of measure. All users of these products should contact LifeScan for instructions.
2.
For ALL
OneTouch Ultra, OneTouch FastTake, EuroFlash, SmartScan, PocketScan and InDuo Systems, an event such as dropping the meter while in
use can, on very rare occasions, cause a brief power loss. As a result, the
meter may unexpectedly change the unit of measure and/or the code number. Each
time you test make sure your meter's unit of measure is set to "mmol/L," and that the code number on the meter's
display matches the code number on the test strip vial. This very rare power
loss may also affect the meter's 14- and/or 30-day averages. If your averages
are not what you expect, you should not rely on them.
How to Check Your
Meter's Unit of Measure
Each
time you turn on your meter, the unit of measure will appear on the display
with the symbol. The unit of measure will also appear under every test result.
If
your meter is set to the right unit of measure, "mmol/L" will appear on the display. Your test result will include a decimal point. Do Not change this
setting - this is the right unit of measure for your country.
If
your meter is set to the other unit of measure, "mg/dL" will appear on the display.
The test result will not include a
decimal point. Unless your doctor has told you to use this unit of measure, do
not test your blood glucose. Contact LifeScan
immediately for assistance.
How To Contact LifeScan
LifeScan
Customer
Care Freephone:
NOTE: A similar
warning has been issues to people in countries where mg/dL
is the unit of measure